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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biomicroscope, Slit-Lamp, Ac-Powered
510(k) Number K880920
Device Name LASER FLARE CELL METER FC-1000
Applicant
Kowa Optimed, Inc.
20001 S. Vermont Ave.
Torrance,  CA  90502
Applicant Contact HIROSHI OKADA
Correspondent
Kowa Optimed, Inc.
20001 S. Vermont Ave.
Torrance,  CA  90502
Correspondent Contact HIROSHI OKADA
Regulation Number886.1850
Classification Product Code
HJO  
Date Received03/04/1988
Decision Date 09/27/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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